NanoHive Medical has received 510(k) Clearance from the U.S Food and Drug Administration (FDA) for its Hive™ Standalone Cervical System. The implant system features both a zero profile design, interfixated with two self-tapping screws, as well as a cage and plate fixation option.
Both interbody cage options are available in multiple footprints, heights and lordoses to accommodate patient anatomy and feature the innovative Hive™ Soft Titanium® technology.
Patrick O’Donnell, President & CEO of NanoHive Medical remarks that “This FDA Clearance represents a very exciting and momentous achievement for the company. With the Q1, 2023 launch of the Hive™ Standalone Cervical System, combined with our Hive™ Standalone Anterior Lumbar System, the company is positioned as the leader of 3D printed titanium anterior stand-alone fusion systems. Additionally, the new cervical system is ideally designed to address the rapid migration of cervical fusion procedures to ambulatory care surgery center facilities.
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NanoHive Medical, LLC is a pioneer and leading innovator in 3D printed spinal interbody fusion implants and instrumentation. The company’s proprietary, biomimetic Soft Titanium® technology clearly distinguishes their products in the $1.9B spinal interbody fusion device market. The Hive™ portfolio of interbody fusion devices provide surgeons and their patients ideal biomechanical elastic modulus properties, clear and precise diagnostic imaging capability, osteoblast cell attraction and integration – all features that lead to consistently strong fusion constructs and efficacious clinical experiences.
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